Feasibility of Neural Feedback for Lower Limb Amputees

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Louis Stokes VA Medical Center
Study ID
NCT03409133
Status
Recruiting
Apply to this trial

Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stimulating nerve electrodes and intramuscular recording electrodes — DEVICE
    See Arm Description

Study Details

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Key Dates

Start date
Nov 5, 2015
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Stimulating nerve electrodes & intramuscular recording electrodes
    Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads. During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes. Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.

Primary Outcome Measure

Stimulation Thresholds [ Time Frame: 9 months post implant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical CenterClevelandOhio44106
Aarika Sheehan, PT, DPT
[email protected]
216-791-3800
Ronald Triolo, PhD (PRINCIPAL_INVESTIGATOR)

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Louis Stokes VA Medical Center· Cleveland, OH

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